Dr Reddy's Laboratories Ltd announced it's wholly-owned subsidiary in USA is continuing its voluntary nation-wide recall of lot ABD807 of Levetiracetram in 0.54 per cent Sodium Chloride injection, 1,500 mg/100 mL (15 mg/mL) single-dose infusion bags to the hospital level in the North American country.
According to a letter written to the US Food and Drug Administration on Februray 4, the drug maker said the recall, which began in October 2018, was originally initiated due to a product complaint received for mislabelling.
"The pre-printed text content on the infusion bag (primary container) for the lot indicates product information as Levetiracetam in 0.75 per cent Sodium Chloride injection (1,000mg/100mL). The label on the external foil pouch has the product information as Levetiracetam in 0.54 per cent Sodium Chloride Injection (1,500mg/100mL). To date, there have been no reports of adverse events related to this recall," Dr Reddys said.
Levetiracetam injection is an anti-epileptic drug indicated for adjunct therapy in adults on certain types of seizures when oral administration is temporarily not feasible.
Patients who may have been administered the mislabelled product could experience adverse reactions such as somnolence, agitation, aggression, depressed level of consciousness, respiratory depression and coma related to overdosage, it said.
The batch was distributed in the USA between August 14, 2018 and September 5, 2018.
Dr Reddy's Laboratories Inc has notified the distributors to arrange for return of any recalled product.
Wholesalers, distributors, hospitals and pharmacies with an existing inventory of the lot being recalled, should stop use and distribution and quarantine the product immediately for return/replacement of all recalled products, the drug maker said.